Automated Intraoperative Lung Recruitment Maneuvers in Major Laparoscopic Surgery

NCT07349784 | Recruiting

• 1 other identifier: BakirkoySadiKonukAnesthesia
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic colorectal surgery is associated with an increased risk of intraoperative atelectasis due to pneumoperitoneum, Trendelenburg positioning, and prolonged anesthesia duration. Atelectasis developing during surgery may persist into the postoperative period and contribute to postoperative pulmonary complications. Automated lung recruitment maneuvers delivered by modern anesthesia ventilators may offer a standardized method to improve lung aeration and reduce atelectasis. This prospective, randomized, single-center controlled trial aims to evaluate the effect of automated intraoperative lung recruitment maneuvers on atelectasis detected by lung ultrasonography in patients undergoing elective major laparoscopic colorectal cancer surgery. Adult patients will be randomized to receive either automated lung recruitment maneuvers or standard mechanical ventilation without recruitment. Lung ultrasonography will be used to assess atelectasis at predefined perioperative time points. The primary outcome is the incidence of atelectasis detected by lung ultrasound, and secondary outcomes include postoperative pulmonary complications, length of intensive care unit stay, length of hospital stay, and perioperative hemodynamic instability.

Conditions

Atelectasis; Postoperative Pulmonary Complications (PPCs)

Keywords

Lung Ultrasound Score (LUS); Automated Lung Recruitment Maneuvers; Laparoscopic Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• Atelectasis detected by lung ultrasonography

  The presence and severity of atelectasis will be assessed using lung ultrasonography performed with a standardized 12-zone scanning protocol. Lung ultrasound scores (LUS) will be calculated for each zone, and severe atelectasis will be defined as a lung ultrasound score of 2 or 3 in any lung region.Lung ultrasound score (LUS) will be assessed using a standardized 12-zone lung ultrasonography protocol. Each lung zone will be scored from 0 to 3 (0 = normal aeration, 1 = moderate loss of aeration, 2 = severe loss of aeration, 3 = consolidation), resulting in a total score ranging from 0 to 36. Higher LUS values indicate worse lung aeration.

  Preoperative baseline (before anesthesia induction), intraoperative assessment (after induction and before pneumoperitoneum), early postoperative assessment (30 minutes after extubation), and postoperative day 1 (within 24 hours after surgery).

Secondary Outcomes (3)

• Postoperative pulmonary complications

  From the end of surgery until hospital discharge (up to postoperative day 30).

• Change in lung ultrasound score (LUS)

  From preoperative baseline through postoperative day 1

• Oxygenation parameters (PaO₂/FiO₂ ratio)

  Intraoperatively,immediediately after the first recruitment maneuver(within 10 minutes after the maneuver) and during the early postoperative period (30 minutes after extubation).

Other Outcomes (2)

• Length of intensive care unit stay

  From postoperative intensive care unit admission until discharge from the intensive care unit (up to 30 days).

• Length of hospital stay

  From the day of surgery until hospital discharge(up to 30 days)

Study Arms (2)

Control Group

NO INTERVENTION

Participants assigned to the control group will receive standard intraoperative mechanical ventilation according to institutional practice during general anesthesia for laparoscopic colorectal surgery. No lung recruitment maneuvers will be performed. Perioperative monitoring, anesthetic management, and postoperative care will be standardized and identical to those of the intervention group, except for the application of automated lung recruitment maneuvers.

Automated Recruitment Group

EXPERIMENTAL

Participants in the intervention group will receive standard intraoperative mechanical ventilation plus automated lung recruitment maneuvers performed by the anesthesia ventilator. The automated recruitment protocol will be applied twice: once after induction of anesthesia and before the initiation of pneumoperitoneum, and once again after pneumoperitoneum is terminated. All other anesthetic management, monitoring, and postoperative care will be identical to the control group.

Procedure: Automated Intraoperative Lung Recruitment Maneuvers

Interventions

Automated Intraoperative Lung Recruitment Maneuvers PROCEDURE

Automated lung recruitment maneuvers will be performed intraoperatively using the anesthesia ventilator in pressure-controlled ventilation mode according to a standardized protocol.

Automated Recruitment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years
• Scheduled for elective laparoscopic colorectal cancer surgery
• American Society of Anesthesiologists (ASA) physical status I-III

You may not qualify if:

• ASA physical status IV or higher
• Pregnancy
• Body mass index (BMI) \> 40 kg/m²
• Severe chronic obstructive pulmonary disease (COPD), GOLD stage III-IV
• Advanced heart failure with left ventricular ejection fraction \<35%
• Previous thoracic surgery
• Preoperative requirement for supplemental oxygen therapy
• Refusal or inability to provide informed consent
• Intraoperative conversion to open surgery
• Development of significant hemodynamic instability during lung recruitment maneuvers

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

SBÜ Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• Shander A, Fleisher LA, Barie PS, Bigatello LM, Sladen RN, Watson CB. Clinical and economic burden of postoperative pulmonary complications: patient safety summit on definition, risk-reducing interventions, and preventive strategies. Crit Care Med. 2011 Sep;39(9):2163-72. doi: 10.1097/CCM.0b013e31821f0522.

  PMID: 21572323 BACKGROUND

• Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

  PMID: 25058504 BACKGROUND

• Nakahira J, Nakano S, Minami T. Evaluation of alveolar recruitment maneuver on respiratory resistance during general anesthesia: a prospective observational study. BMC Anesthesiol. 2020 Oct 17;20(1):264. doi: 10.1186/s12871-020-01182-9.

  PMID: 33069208 BACKGROUND

• Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.

  PMID: 28186222 BACKGROUND

• Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.

  PMID: 27669555 BACKGROUND

• Yu X, Zhai Z, Zhao Y, Zhu Z, Tong J, Yan J, Ouyang W. Performance of Lung Ultrasound in Detecting Peri-Operative Atelectasis after General Anesthesia. Ultrasound Med Biol. 2016 Dec;42(12):2775-2784. doi: 10.1016/j.ultrasmedbio.2016.06.010. Epub 2016 Sep 14.

  PMID: 27639431 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sena Gökçe Karataş

CONTACT

+90 212 414 71 71; senagokce_96@outlook.com

Evrim Kucur Tülübaş

CONTACT

+90 212 414 71 71; kucurevrim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 20, 2026
• Study Start: December 13, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)